MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; COMPRESSOR,NEBULIZER, CHARACTER, PUP

Catalog Number	HCSPUPPYH
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Cough (4457)
Date of Event	06/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 the nebulizer "stopped misting" the "albuterol" medication causing her daughter to develop a "congestive cough".The customer reported her daughter takes the medication "as needed" to treat her "asthma".The customer reported after the cough developed she called her physician who prescribed "prednisone oral medication for 5 days".The customer did not report any serious injury, medical intervention, or follow-up care related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2024 the nebulizer "stopped misting" the "albuterol" medication causing her daughter to develop a "congestive cough".

• Common Device Name: COMPRESSOR,NEBULIZER, CHARACTER, PUP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19822385
• Report Number: 1417592-2024-00768
• Device Sequence Number: 18316514
• Product Code: BTI
• UDI-Device Identifier: 00888277678166
• UDI-Public: 00888277678166
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: HCSPUPPYH
• Device Lot Number: 6462212
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown